Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

Sjögren's Syndrome Clinical Trial

Official title:

Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02855658
• Other study ID #: CMUH105-REC3-025
• Status: Recruiting
• Phase: Phase 2
• First received: July 13, 2016
• Last updated: August 1, 2016
• Start date: February 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: China Medical University Hospital
• Contact: Hen-Hong Chang, M.D., Ph.D.
• Phone: +886-3196200
• Email: tcmchh55[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: National Science CouncilTaiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

Description:

Objective: To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

Method:

The evidence of the regulation of oxidative-related cytokines and the antioxidant capacity could be provided from the previous randomized, double-blinded, placebo-controlled, cross-over design, two-center clinical trial for evaluating the effect of Chinese herbal medicine (SS-1) for the Sjögren's syndrome patients. However, the clinical trail could not find out the modulation of immunity-related gene expression for SS-1 treatment, and it did set up a healthy control group for SS-1 comparison. This study want to establish a healthy control group for evaluating the normal range of oxidative stress and cytokines, which this work could be used to compare with the 72 SS-1 subjects in previous study. And This study also want to analyze the 770 immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment: (1) The best 20 (at least) efficacy SJS subjects who were evaluated before and after SS-1 treatments. (2) The 10 (at least) healthy control subjects. The findings could provide the evidence on the modulation of immunity-related gene expression for clinical manifestation, oxidative stress and cytokine in Sjögren's syndrome patients.

Expected Results:

1. Establish the normal range of oxidative stress and cytokines for healthy control group.

2. To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group.

3. To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment.

4. To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects.

5. To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis.

6. To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary or Secondary Sjögren's syndrome patient

• Age from 20 to 75 year old, male or female patient

• Fit the criteria of 2002 year American-European classification

• If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month

• If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month

• Secondary Sjögren's syndrome patient:

• Stable treatment: Steroid (?10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled

• No abnormal change of immunology, liver, kidney, and blood function

• No major life threatened condition

Exclusion Criteria:

• Alcohol abuse, DM (Glucose PC>200mg/dL) and major life threatened condition

• Pregnancy or breast feeding

• Abnormal liver and kidney function

• Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Sjögren's Syndrome
• Syndrome

Intervention

Drug:
• SS-1
The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12 weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12 weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.
• Placebo
The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.

Locations

Country	Name	City	State
Taiwan	Taoyuan Chang Gung Memorial Hospital	Gueishan Township
Taiwan	China Medical University Hospital	Taichung

Sponsors (4)

Lead Sponsor	Collaborator
China Medical University Hospital	Chang Gung Memorial Hospital, China Medical University, China, National Research Program for Biopharmaceuticals (NRPB)

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjögren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541. Erratum in: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effect (AE) and Adverse drug reaction(ADR)	Monitor the Adverse effect (AE) and Adverse drug reaction(ADR) during the SS-1 trial.	7 months	Yes
Other	Liver, Kidney and Blood function monitor	Monitor the Liver, Kidney and Blood function monitor (RBC, WBC, Hb, Platelet, AST, ALT, BUN, Cre) of patient during the SS-1 trial, and the different units are listed below: WBC (1000/uL), RBC (million/uL), Hb (g/dL), Platelet (1000/uL), AST (U/L), ALT (U/L), BUN (mg/dL), Serum Creatinine (mg/dL).	7 months	Yes
Other	Traditional Chinese medicine (TCM) tongue diagnosis	To evaluate the effect of the SS-1 on the TCM tongue diagnosis before and after treatment.	7 months	Yes
Primary	Ocular surface disease index (OSDI)	OSDI is an questionnaire of dry eye.	7 months	Yes
Primary	EULAR Sjogren's syndrome patient reported index (ESSPRI)	ESSPRI is an questionnaire of dry, pain and fatigue.	7 months	Yes
Primary	Sjogren's syndrome symptoms Questionnaire	Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.	7 months	Yes
Primary	Schirmer's test	Schirmer's test is an objective detection of dry eye, which this test use paper strips inserted into the eye for 5 minutes to measure the production of tears.	7 months	Yes
Primary	Salivary scintigraphy	Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome.	7 months	Yes
Secondary	Oxidative stress and antioxidant capacity	To evaluate the effect of the SS-1 on the oxidative stress and antioxidant capacity. The "relative ratio" is the unit of these biomarkers for oxidative stress and antioxidant capacity	7 months	Yes
Secondary	Quality of life (SF-36)		7 months	Yes
Secondary	Regulatory effect on cytokine	To evaluate the effect of the SS-1 on the cytokine. The "pg/ml" is the unit of these biomarkers for oxidative stress and antioxidant capacity	7 months	Yes
Secondary	Nanostring nCounter immune Panel	To evaluate the effect of the SS-1 on the immunity-related gene expression. Nanostring nCounter immune Panel is a tool for detecting the immunity-related gene expression.	7 months	Yes

External Links

•   NCT02110446: Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome (SS-1)